• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC RENAISSANCE SYSTEM INSTRUMENT, STEREOTAXIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NAVIGATION, INC RENAISSANCE SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number TPL0038
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Tissue Damage (2104); Impaired Healing (2378)
Event Date 02/20/2017
Event Type  Injury  
Manufacturer Narrative
Date of event. Please note that this date is based off the date of publication of the article as the actual event date was not provided. The reported event was from the following literature article: keric n, doenitz c, haj a, rachwal-czyzewicz i, renovanz m, wesp d, boor s, conrad j, brawanski a, giese a, kantelhardt s. Evaluation of robot-guided minimally invasive implantation of 2067 pedicle screws. Neurosurgical focus. 2017. 42 (5). Doi: 10. 3171/2017. 2. Focus16552. (b)(4). If information is provided in the future, a supplemental report will be issued. (b)(4).
 
Event Description
Abstract: recent studies have investigated the role of spinal image guidance for pedicle screw placement. Many authors have observed an elevated placement accuracy and overall improvement of outcome measures. This study assessed a bi-institutional experience following introduction of the renaissance miniature robot for spinal image guidance in europe. The medical records and radiographs of all patients who underwent robot-guided implantation of spinal instrumentation using the novel system (between october 2011 and march 2015 in mainz and february 2014 and february 2016 in regensburg) were reviewed to determine the efficacy and safety of the newly introduced robotic system. Screw position accuracy, complications, exposure durations to intraoperative radiation, and reoperation rate were assessed. Of the 413 surgeries that used robotic guidance, 406 were via a minimally invasive approach. In 7 cases the surgeon switched to conventional screw placement, using a midline approach, due to referencing problems. Atotal of 2067 screws were implanted using robotic guidance, and 1857 screws were evaluated by postoperative ct. Of the 1857 screws, 1799 (96. 9%) were classified as having an acceptable or good position, whereas 38 screws (2%) showed deviations of 3¿6 mm and 20 screws (1. 1%) had deviations > 6 mm. Nine misplaced screws, implanted in 7 patients, required revision surgery, yielding a screw revision rate of 0. 48% of the screws and 7 of 406 (1. 7%) of the patients. The mean ± sd per-patient intraoperative fluoroscopy exposure was 114. 4 (± 72. 5) seconds for 5. 1 screws on average and any further procedure required. Perioperative and direct postoperative complications included hemorrhage (2 patients, 0. 49%) and wound infections necessitating surgical revision (20 patients, 4. 9%). The hexapod miniature robotic device proved to be a safe and robust instrument in all situations, including those in which patients were treated on an emergency basis. Placement accuracy was high; peri- and early postoperative complication rates were found to be lower than rates published in other series of percutaneous screw placement techniques. Intraoperative radiation exposure was found to be comparable to published values for other minimally invasive and conventional approaches. Reported events: 1 - 5 patients who underwent procedures using the robotic guidance system required revision surgeries for screw deviations. 2 - 2 patients who underwent procedures using the robotic guidance system required revision surgeries for anterior vertebral perforation and contact with the abdominal aorta. 3 - 20 patients who underwent procedures using the robotic guidance system experienced problems with wound healing and needed a revision surgery. 4 - 2 patients who underwent procedures using the robotic guidance system experienced postoperative csf-fistula and wound healing problems that required a revision surgery. 5 - a patient who underwent a procedure using the robotic guidance system experienced new neurological deficits post-operatively and a revision surgery was required. The patient experienced paraplegia due to an epidural thoracic hematoma, immediately underwent reoperation and had recovered. 6 - a patient who underwent a procedure using the robotic guidance system experienced new neurological deficits post-operatively and a revision surgery was required. The patient experienced nerve root injury due to a misplaced screw. Reoperation was completed immediately and the patient recovered. 7 - 4 patients who underwent procedures using the robotic guidance system experienced pneumonia during the postoperative course. 8 - 2 patients who underwent procedures using the robotic guidance system experienced pulmonary embolism during the postoperative course.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRENAISSANCE SYSTEM
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8904456
MDR Text Key156900736
Report Number1723170-2019-04515
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K120812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 08/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTPL0038
Device Catalogue NumberTPL0038
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/18/2019 Patient Sequence Number: 1
-
-